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Not yet recruiting NCT07365657

Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI vs Miniplates

— Observational Malocclusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: In silico orthognathic surgery with customized implants digital only on 3D scanners.
Who it may be relevant to
Registry conditions: Malocclusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Subject-specific Finite Element Modelling of Le Fort I Osteotomy Fixation : Patient-specific Implants vs Miniplates

Overview

This study aimed to evaluate the biomechanical performance of patient-specific versus conventional fixation for Le Fort I osteotomy using subject-specific finite element models derived from real surgical plans. Two distinct clinical scenarios-a minor advancement without impaction and a moderate advancement with posterior impaction-were analyzed to determine how surgical movements influence implant stress, bone stress, and maxillary micromotion. By combining surgical planning with validated computational modeling, this work provides clinically relevant insight to optimize PSI design and guide fixation strategy selection in orthognathic surgery.

Interventions

  • Other In silico orthognathic surgery with customized implants digital only on 3D scanners
    2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery

Primary outcome measures

  • Plate stress levels [Time frame: At the inclusion]
Secondary outcome measures (2)
  • Stress on bone [Time frame: At the inclusion]
  • Maxillary displacement [Time frame: At the inclusion]

Eligibility criteria

Inclusion criteria

  • Patient operated on By Pr SAVOLDELLI.
  • Patient undergoing patient-specific orthognathic surgery.
  • Access to numerical (digital) planning.

Exclusion criteria

  • Previous maxillo-facial trauma.
  • Facial cleft.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 1 center
  • CHU Nice — Nice

Identifiers

NCT: NCT07365657 · 26IUFC01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗